PET imaging of neuroendocrine tumours
- Conditions
- euroendocrine tumourTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2012-002513-19-SE
- Lead Sponsor
- Karolinska University Hospital Solna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients with neueoendocrine tumour in need of somatostatin receptor imaging for staging of the disease, depiction of the primary tumour and patients with medullary thyroid cancer in need for pre-operative lymph node mapping.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
Exclusion Criteria
Age less than 18 years
Claustrofobia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: This is an exploratory observational Phase II trial to investigate the imaging capacity of 68Ga-DOTATOC-PET/CT in patients with neuroendocrine tumours and medullary thyroid cancer in comparison with either Whole-Body-Magnetic Resonance Imaging using Diffusion Weighted Signal sequences (DWI-MRI) and in comparison with conventional radiological procedures such as CT and US and long term follow-up.;Secondary Objective: There are no secondary endpoints in this trial;Primary end point(s): When both PET/CT and WB-MRI has been performed and compared and correlated to findings at surgery, histopathology and radiological and clinical follow-up;Timepoint(s) of evaluation of this end point: Varying, because some patients undergo surgery and histopathology immediately after PET/CT and MRI and others needs to be followed radiological and clinically for longer time.
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: There are no secondary endpoints in this trial;Secondary end point(s): There are no secondary endpoints in this trial